The need for the introduction of laparoscopic postpartum
sterilisations in the public healthcare sector in South Africa (SA) has
been identified through the weaknesses found in the current practice of
performing all postpartum sterilisations (PPS) as open procedures. The
international literature contains many reports of the advantages of
doing the procedure laparoscopically, and the feasibility of the
procedure, although once disputed, is widely accepted. [1-3] The aim of
our study was primarily to prove feasibility and assess advantages of
postpartum laparoscopic sterilisation in a public healthcare facility in
SA, as a developing country. Our secondary aims were to assess the ease
of the procedure and complication rates, to illustrate the
procedure's proposed impact on hospital stay and operating time and
to ascertain the potential of the procedure to increase postpartum
sterilisation rates in the future.

Methods

The study is a retrospective descriptive study and reviews all
clinical records of patients who underwent both open and laparoscopic
postpartum sterilisations at Worcester Hospital, a secondary level
hospital in the Western Cape Province, SA, between June 2012 and
December 2013.

Postpartum sterilisation is defined as a sterilisation performed
within 72 hours of the vaginal delivery of a viable baby. (In our
setting viability is defined as 28 weeks or 1 000 g). Excluded from the
study were sterilisations performed more than 72 hours after vaginal
delivery, any sterilisation performed after the delivery of a non-viable
fetus and any sterilisation performed concurrently with any other
procedure (e.g. caesarean section, perineal tear repair).

Laparoscopic and open sterilisations were performed under local,
regional or general anaesthesia as decided by the anaesthetist involved
in the case. Laparoscopic sterilisations were performed with a
Falope-Ring applicator/bipolar grasper and open sterilisations by means
of the modified Parklands method. Laparoscopic sterilisations were all
performed with two ports, an upper umbilical abdominal entry site with
either a 10 mm or 5 mm port for a 30 [degrees] lens and a 7 mm
suprapubic port for the Falope-Ring applicator. Insufflation was with a
Veress needle if the patient had no prior midline surgery and
intra-abdominal adhesions were not suspected, and otherwise with an open
Hasson technique or insufflation at Palmer's point. After
completion of the sterilisation the sheath was closed with the 10 mm
ports and skin closure was with polyglactin dissolvable sutures.

The open procedure was performed with a 2 - 4 cm sub-umbilical
incision using the modified Parklands method, which includes the
ligation and excision of a portion of the fallopian tube. The sheath was
closed with absorbable sutures and the skin with absorbable sutures or
skin clips. Duration of surgery was defined from first incision to skin
closure.

Patient information was obtained though the theatre and labour ward
registers, as well as a computer database of all surgeries performed at
Worcester Hospital. Folders of these patients were then requested, and
the hardcopy folder was audited according to certain defined parameters
and information recorded on an anonymous data capture sheet. Patients
with incomplete records, interval procedures or non-viable deliveries
were excluded. Information from the data capture sheets was entered into
an Excel spreadsheet (Microsoft Corp., USA) for analysis.

Data analysis was performed using means and standard deviations
(SDs) and the two-sample t-test for normally distributed data. The
median and range with the two-sample Wilcoxon rank-sum test was used
with data not normally distributed. The x2 test without Yates'
correction was used for qualitative data analysis. There was no need for
informed consent for the study because it was a retrospective review and
no funding was required.

Ethical approval was obtained from the Stellenbosch University
Health Research Ethics Committee (S13/08/139). Additional approval was
obtained from the chief executive officer of Worcester Hospital and the
Western Cape Department of Health.

Results

During the study period between July 2012 and December 2013, 425
sterilisations were performed at Worcester Hospital. Excluded from the
study were sterilisations performed with caesarean section (n=217),
sterilisations performed in conjunction with other procedures (n=8),
interval sterilisations (n=57) and sterilisations with missing folders
(n=47). Of the 96 postpartum sterilisations performed, 18 were excluded
because of incomplete notes, 26 sterilisations were performed open via
mini-laparotomy and 52 were performed laparoscopically.

The main outcome measures were chosen to assess the feasibility and
possible advantages of this procedure in a public hospital in SA. The
demographic data were chosen to describe the patients in whom this
procedure is practical, including patients with an increased body mass
index (BMI).

One main outcome was duration of surgery of sterilisations
performed via mini-laparotomy compared with the laparoscopic procedure.
This outcome was divided into three groups: the first group assessed the
time difference between all open v. laparoscopic procedures; the second
group assessed time differences in duration of surgery in laparoscopic
v. open procedures among patients with a BMI >30; and the third group
compared duration of surgery of laparoscopic v. open procedures
performed by surgeons with intermediate experience (community service
doctors, medical officers and registrars). Outcomes also included the
time the patient had to wait post delivery before the sterilisation
procedure (hours) and the length of stay postoperatively (days).

The total complications experienced in open v. laparoscopic
sterilisations were recorded. These complications were divided into
complications occurring during surgery, early complications (before
discharge) and late complications (after discharge, excluding failed
sterilisations).

Laparoscopic sterilisations were all performed under general
anaesthesia with a Falope-Ring applicator. All but one of the open
procedures were performed under general anaesthesia (one case spinal
anaesthesia). All open procedures were performed through a sub-umbilical
incision and the sterilisation was performed using the modified
Parklands method. There were seven patients with previous abdominal
surgery in the postpartum laparoscopic group. Only one patient had a
non-umbilical (Palmer's point) entry site and this was due to a
previous midline incision. The six patients with previous Pfannenstiel
incisions had an uncomplicated entry through an umbilical incision. In
all laparoscopic cases insufflation was with the use of a Veress needle.

All patients had a single consent form from the Provincial
Administration of the Cape of Good Hope, including a checklist.

Demographics were similar between the two groups, with mean age and
parity being almost identical (Table 1). On average the laparoscopic
group had a slightly higher BMI with a maximum BMI of 46 compared with
the maximum BMI in the open group of 38.8. (The maximum BMI managed at
Worcester Hospital is 49 because of anaesthetic risk.)

Total duration of surgery was found to be 3.7 minutes shorter in
the laparoscopic than the open group (95% confidence interval (CI) -1.1
- 8.5; p=0.08) (Table 2). Duration of surgery in the subgroup of
patients with a BMI >30 was 4.9 minutes shorter in the laparoscopic
group (n=21) compared with the open group (n=6) (95% CI -5.3 - 15.2;
p=0.83). Lastly, comparing duration of surgery within the subgroup of
intermediate surgeons revealed that the open procedure (n=22) was 0.65
minutes shorter than the laparoscopic procedure (n=21) (95% CI -7.3 -
6.0; p=0.81).

Average waiting time post delivery for the sterilisation procedure
was 13.5 hours in the open group and 17.7 hours in the laparoscopic
group (Table 3). Length of stay in hospital was comparable between the
two groups but more laparoscopic patients were discharged on the same
day as the procedure.

Total complications were found to be fewer in the laparoscopic
group (odds ratio (OR) 0.35, 95% CI 0.08 - 1.43; p=0.14) (Table 4).
Complications experienced during surgery in the open group included
bleeding from the muscle and sheath (n=1), suture slipped with bleeding
(n=1), and difficulty finding tube (n=1). In the laparoscopic group the
three complications during surgery were instrument failure (n=2) and
transection of the tube with bleeding that was stopped by a bipolar
grasper without converting to an open procedure (n=1).

Early complications (that occurred before discharge of the patient)
included two complications in the open group consisting of postoperative
pyrexia of unknown origin and a wound haematoma that was treated
conservatively. In the laparoscopic group, one early complication
occurred involving wound dehiscence of a 10 mm umbilical incision
needing closure in theatre. No late complications were reported in
either group.

A total of six complications (out of nine) were associated with the
group of intermediate surgeons; five of these were during an open
procedure and one during a laparoscopic sterilisation.

Discussion

SA has an unintended pregnancy rate of 59% and a teenage pregnancy
rate of 4.9%. [4] There is a 25% unmet need for family planning in women
who are married or in a union. [5] There is a large problem with loss to
follow-up, especially in young women who are/have recently been
pregnant. [6] Women over the age of 15 who are clinically obese (BMI
[greater than or equal to] 30) number 12.5%, with a 35.7% prevalence of
obesity among urban African women. [7] Attitudes towards sterilisation
may be influenced by cultural beliefs about fertility, accessibility to
services and the sociopolitical history of SA during and after
apartheid. [8] Negative influences on the attitude towards sterilisation
could also include failure to obtain requested sterilisation (most often
due to physician dissuasion) [9,10] and the stigma surrounding the
forced sterilisation of HIV-positive women. [11]

There is much international literature describing the advantages of
laparoscopic methods for sterilisation over an open procedure resulting
in fewer instances of minor operative morbidity, shorter duration of
surgery, minimal scarring and less postoperative discomfort. [1,2] This
was confirmed by the results of this study with up to 5 minutes'
shorter duration of surgery (especially in the high-BMI group) and fewer
overall complications (OR 0.35). A small case review by Garcia-Padial et
al. [12] looking at laparoscopic postpartum sterilisation in women with
a BMI >35 shows that the laparoscopic procedure is faster than an
open procedure in women of similar weights with no reported
complications. This proves that this procedure is safe and effective in
the increasing proportion of women in SA with BMIs over 30. A study by
Huber et al. [3] that reviewed 27 653 women undergoing sterilisation in
Switzerland concluded that laparoscopic sterilisation, whether performed
as an interval or postpartum procedure, is superior over a postpartum
mini-laparotomy in terms of major and minor complications.

An interesting secondary outcome of our study is that intermediate
surgeons (community service doctors/medical officers/ registrars) with
little or no previous laparoscopic experience took almost the same
length of time to perform the laparoscopic as the open procedures, with
fewer complications. In many countries it is mostly experienced surgeons
who perform laparoscopic work, but in SA, however, the intermediate
surgeons drive the maternal service and are responsible for almost all
sterilisations performed. The authors were unable to adequately assess
the learning curve of these doctors as numbers of sterilisations
performed by each was too few, but this may be a topic for future
research.

A topic of controversy surrounding this procedure is that of
sterilisation method and sterilisation failure. It has been widely
taught that sterilisations performed during the puerperium have an
increased failure rate. Although there are studies showing an increase
in failure rates when sterilisation is performed post partum, [13] there
are often many confounding factors, including surgeon experience, method
used and follow-up. There are also studies which show no association
between timing of sterilisation and failure, [14] and the US
Collaborative Review of Sterilisation, the longest cumulative outcome
study on various sterilisation methods, found that the postpartum
partial salpingectomy, the only method being performed post partum, had
the lowest cumulative probability of sterilisation failure compared with
other interval methods. [15] Factors associated with an increased risk
of sterilisation failure that were consistent were lower age and less
surgeon experience. [13-15]

Methods of laparoscopic sterilisation include electrocoagulation,
silicone band and clip being the most common. Mechanical devices have
traditionally been preferred to electrocoagulation owing to risk of
bowel injury with unipolar coagulation and poor outcomes of
sterilisation reversal as a result of the destruction of tissue. [16]
Both the Filshie clip and Falope/Yoon ring have had varied studies of
varying sizes performed, with varying follow-up intervals to assess
their efficacies. [13-17] As expected, results on failure rates are
extremely varied and are influenced by surgeon experience, technique
used, age of patient and duration of follow-up. [18] It is therefore
difficult for these authors to say with any certainty that one method is
superior to the other, especially in a postpartum situation.
Sterilisation failure was not a primary outcome in our study as it was a
retrospective review with no confirmatory imaging (e.g.
hysterosalpingogram) or follow-up interviews. A long-term cumulative
outcome study is needed on different methods of laparoscopic postpartum
sterilisation.

Suggested surgical techniques resulting from experience gained by
the authors during the course of the study include:

* The surgeon must ensure that the instruments are functional
before the administration of anaesthetic or first incision made.

* A blade facing upwards will prevent a skin incision that is too
deep on entry.

* An upper umbilical site for abdominal entry is usually
uncomplicated and performed easily in a postpartum patient. There may be
instances, however, where a supra-umbilical or non-umbilical site
(Palmer's point) is preferable, e.g. previous pelvic surgery.

* Retracting the fallopian tube slowly into the applicator will
reduce the incidence of tubal transection.

* The round ligament, tube and fimbrial ends must be reviewed
before closure to avoid the chance of operator-related sterilisation
failure.

Lastly, we have found that it is practical to keep the laparoscopic
set simple and small with reusable instruments. The instruments that
were used are detailed in Table 5.

Some recommendations for future research would include looking at
the acceptability of the laparoscopic procedure among the SA patient
population, the long-term follow-up of sterilisation failure from this
procedure, an assessment of anaesthetic options to provide an ambulatory
service and a quality improvement study to assess ways of improving the
provision of requested postpartum sterilisations.

Strengths of the study were that it was a review of procedures
performed in the population for which we are assessing its advantages.
It is applicable to the limitations of the SA health service and the
limited experience of surgeons in laparoscopic surgery, particularly in
the public sector.

A limitation of this study is that it is a retrospective review of
clinical records and was limited by the quality of note-keeping of the
cases studied. Because it was retrospective, there was no randomisation
of patients and therefore patients might have undergone selection bias
as to which procedure was performed. Confounding factors may include
surgeon experience, time of delivery and BMI.

Conclusion

It is feasible, safe and advantageous to provide a laparoscopic
postpartum sterilisation service in SA. The service would allow patients
to experience a procedure that has multiple advantages over open
surgery, especially in a population such as in SA with a high loss to
follow-up for interval procedures and changing demographics such as BMI.